Radiology · 510(k) · 2018
FerriSmart Analysis System
Resonance Health Analysis Services Pty Ltd. Cleared by FDA on 30 November 2018 under submission K182218, product code PCS (liver iron concentration imaging companion diagnostic for deferasirox). What FDA's record says, in FDA's words.
Device record · K182218
- Device. FerriSmart Analysis SystemDEVICE
- Company. Resonance Health Analysis Services Pty Ltd (AU)COMPANY
- Decision. 30 November 2018, 510(k), substantially equivalent (traditional review); received 15 August 2018DECISION
- Panel. RadiologyPANEL
- Product code. PCS, Liver Iron Concentration Imaging Companion Diagnostic For DeferasiroxCODE
- Regulation. 21 CFR 892.1001, Class IIREG
- Source. FDA database entry · decision document (12 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
FerriSmart is indicated to: • measure liver iron concentration in individuals with confirmed or suspected systemic iron overload; • monitor liver iron burden in transfusion dependent thalassemia patients and patients with sickle cell disease receiving blood transfusions; • aid in the identification and monitoring of non-transfusion-dependent thalassemia patients receiving therapy with deferasirox.
The product code's definition, from FDA's classification record. Intended for diagnostic use to present images that reflect the magnetic resonance spectra for the determination of iron in the liver for any indication where an assessment of liver iron concentration is needed. For non-transfusion-dependent thalassemia (NTDT) patients, is intended as an aid in the assessment of NTDT patients for whom deferasirox therapy is being considered and for monitoring of NTDT patients receiving deferasirox therapy.
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Mentionsdetection or identification of findings
- Mentionsmeasurement or quantification
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 0 reports filed against devices carrying product code PCS. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification.
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code PCS, in Radiology, from Resonance Health Analysis Services Pty Ltd, or cleared in 2018. The whole record is at FDA AI-enabled medical devices.
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